Document Details

SUPPLEMENT: Protected and/or Vulnerable Populations

Purpose

This supplement, to be used in conjunction with the IRB Application: Standard, or Modification Form, asks for required regulatory information such that the IRB can ensure the research is compliant with the numerous regulations governing the participation of protected and/or vulnerable populations in research.

Change Notes

Added a fourth option for illiterate individuals to harmonize with SOP on Consent Documentation. Please use this version going forward.

- sherrye

Related to Ver. 3.20, noted 10/31/2014 @ 11:17am

Modified Prisoners section to be in line with Flexibility Policy. Use this version going forward.

- sherrye

Related to Ver. 3.10, noted 04/03/2014 @ 05:18pm

Added clarification that COPPA refers to collecting information about children online.

- sherrye

Related to Ver. 3.00, noted 11/22/2013 @ 09:27am

Added question regarding COPPA regulation.

- sherrye

Related to Ver. 2.90, noted 11/01/2013 @ 01:28pm

Updated new assent questions. Use this version going forward.

- sherrye

Related to Ver. 2.80, noted 10/19/2013 @ 04:49pm

Updated name to new naming convention on website.

- sherrye

Related to Ver. 2.80, noted 08/30/2013 @ 09:03am

Added section for researchers to request a waiver of assent for children.

- sherrye

Related to Ver. 2.70, noted 05/31/2013 @ 09:24am

Corrected small error. Okay to use previous version.

- sherrye

Related to Ver. 2.60, noted 03/30/2012 @ 09:16am

Corrected typo. Okay to use previous version.

- sherrye

Related to Ver. 2.60, noted 12/30/2011 @ 09:18am

Added note regarding children who are wards and the use of ward advocates.

- sherrye

Related to Ver. 2.50, noted 04/29/2011 @ 08:59am

Last section, question 6, changed for clarity: Other potentially vulnerable groups – Check all that apply only if you are intentionally recruiting/targeting these vulnerable groups for enrollment into this study.

- sherrye

Related to Ver. 2.40, noted 04/11/2011 @ 08:37am

Updated link to OHRP regulations in section C. Now directs to comprehensive FAQ.